VITEK® 2 GN ID TEST KIT
Received Jan 31, 2017
Report 1950204-2017-00035 · MDR key 6289472
Device
Generic name
Vitek® 2 Gn Id Test Card
Manufacturer
Biomerieux, IncCatalog number
21341
Lot number
241371840
Product problems
- Incorrect Or Inadequate Test Results
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Description of Event or Problem
A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF A BORDETELLA AVIUM EXTERNAL QUALITY CONTROL SAMPLE AS BORDETELLA HINZII, IN ASSOCIATION WITH VITEK® 2 GN ID TEST KIT. THE CUSTOMER STATED THE TEST WAS PERFORMED ONCE AND THE ISOLATE IS NOT AVAILABLE. A BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.
Additional Manufacturer Narrative
AN INTERNAL INVESTIGATION WAS CONDUCTED FOR A MISIDENTIFICATION OF AN AQL SURVEY SAMPLE #87 OF BORDETELLA AVIUM AS BORDETELLA HINZI FROM THE VITEK® 2 GN CARD. THE STRAIN AND RAW DATA WERE NOT SUBMITTED FROM THE CUSTOMER. BORDETELLA AVIUM IS NOT A SPECIES CLAIMED BY THE VITEK® 2 GN CARD. THE FOLLOWING LIMITATION IS STATED IN THE VITEK® 2 PRODUCT LABELING CONCERNING THE TESTING OF UNCLAIMED SPECIES: "NEWLY DESCRIBED OR RARE SPECIES MAY NOT BE INCLUDED IN THE GN DATABASE. SELECTED SPECIES WILL BE ADDED AS STRAINS BECOME AVAILABLE. TESTING OF UNCLAIMED SPECIES MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION." THE INVESTIGATION CONCLUDED THE VITEK® 2 GN CARD PERFORMED AS INTENDED.